THROMBOLEX™ Inc.

First Patient Enrolled in the RESCUE Trial for

Treatment of Acute Submassive Pulmonary Embolism

New Britain, PA, August 06, 2020 --(PR.com)-- THROMBOLEX™ Inc. has announced that it has
enrolled the first patient in its pivotal RESCUE trial for the treatment of patients with acute submassive
pulmonary embolism (PE) using the BASHIR® Endovascular Catheter, under an Investigational Device
Exemption (IDE) from the FDA. RESCUE is a prospective, single-arm, multicenter trial of
pharmaco-mechanical catheter-directed thrombolysis (CDT) and will enroll up to 125 patients at up to 20
sites in the USA. The first patient was a 50-year old man with a high-risk submassive pulmonary embolus
affecting both lungs, treated at Charleston Area Medical Center, Vascular Center of Excellence, Clinical
Trials Center and WVU Vascular Surgery Center, Charleston, WV by Dr. Aravinda Nanjundappa. He
said, “the patient had an excellent result with no complications following treatment with two BASHIR®
Endovascular Catheters, 5 hours of infusion and a total of 14 mg of r-tPA being administered. We were
privileged to enroll the first patient in this important PE trial using the BASHIR® Endovascular
Catheter.”

The RESCUE study follows on the very successful First-in-Human (FIH) trial completed by
THROMBOLEX™ at the end of last year. The FIH trial met its primary safety and feasibility endpoints,
and showed large and rapid reduction in right heart strain as evidenced by a reduction in RV/LV ratio of
37% (P
The BASHIR® Endovascular Catheter is a pharmaco-mechanical CDT device that received 510(k)
pre-market regulatory clearance for the controlled and selective infusion of physician-specified fluids,
including thrombolytics, into the peripheral vasculature. The goal of RESCUE is to achieve an additional
indication for its use in the treatment of pulmonary embolism. This unique device comprises an array of
six expandable mini-infusion catheters at the distal end of the catheter. When expanded, the infusion
basket creates a channel for immediate blood flow through the culprit clot and rapid reperfusion to the
lungs. This novel mode of action promotes delivery of the body’s own endogenous fibrinolytics,
combined with the administration of exogenous fibrinolytics, throughout multiple cross-sectional areas of
the clot. It also allows for the measurement of PA pressure and oxygen saturations from the catheter tip
during infusion, that in turn allows for the therapy to be customized by the physician based on the degree
of clot lysis assessed physiologically.

About THROMBOLEX™, Inc.

Founded in 2016, THROMBOLEX™, Inc. is engaged in the design, development, manufacture and
distribution of innovative endovascular catheters used in interventional procedures, particularly in
catheter-directed thrombolysis (CDT) of thrombus in patients who suffer from arterial, venous and
arteriovenous thromboembolic conditions. Our innovative technology platform is easy to use, requires no
capital equipment and helps physicians customize therapy plans for their patients. We are also focused on
improving hospital economics as patients treated with our devices typically receive lower doses of
thrombolytic while demonstrating short ICU and overall length of hospital stay. The company is currently
selling seven (7) different FDA-cleared devices that are all based on the BASHIR® Endovascular
Catheter platform technology.

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Contact Brian G. Firth, MD, PhD, FACC, MBA
Chief Scientific Officer
brian@thrombolex.com

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Contact Information:
Thrombolex, Inc.
Dr. Brian G. Firth, MD, PhD, FACC, MBA
(215) 499-8184
Contact via Email
www.Thrombolex.com

Online Version of Press Release:

You can read the online version of this press release at: https://www.pr.com/press-release/818592

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